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FDA approves Johnson & Johnson’s nasal spray for depression

FDA approves standalone use of J&J’s ketamine-derived depression treatment

The U.S. Food and Drug Administration expanded approval for Johnson & Johnson’s nasal spray, Spravato, to allow it to be used as a standalone treatment for patients with severe depression, the company said on Tuesday.

Fox Business · 7h

J&J's ketamine-derived nasal spray approved by FDA to treat depression

Johnson & Johnson's ketamine-derived nasal spray has been approved as a standalone treatment to fight depression for those who had an inadequate response to oral antidepressants.

KSAT · 4h

FDA approves first nasal spray for major depression disorder

The U.S. Food and Drug Administration on Tuesday approved the first nasal spray that will help with treating major depressive disorder.

Reuters on MSN · 15h

US FDA approves J&J's ketamine-based therapy to treat depression

The U.S. Food and Drug Administration approved Johnson & Johnson's ketamine-based nasal spray Spravato to treat adults with major depressive disorder, the company said on Tuesday. The approval paves the way for use of Spravato in patients whose disease has stopped responding to at least two oral anti-depressants.

Boise State Public Radio · 5h

FDA allows standalone use of nasal spray antidepressant Spravato (esketamine)

The FDA says esketamine, an antidepressant derived from the anesthetic and party drug ketamine, can now be prescribed on its own. It was approved in 2019 to treat severe depression.

FDA, Atara Biotherapeutics

AOL · 6h

FDA Places Clinical Hold On Atara Biotherapeutics' Two Cell Therapy Programs

On Tuesday, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Atara Biotherapeutics, Inc.’s (NASDAQ:ATRA) active Investigational New Drug (IND) applications. These INDs include the EBVALLO (tabelecleucel) program for patients two years of age and older with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD),

Business Insider · 6h

Atara Biotherapeutics Faces Uncertainty Amid FDA Clinical Hold and Financing Needs, Resulting in Hold Rating

Atara Biotherapeutics (ATRA – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Benjamin

MarketWatch · 16h

Atara's New Drug Applications Placed on Hold by FDA

Atara Biotherapeutics said the U.S. Food and Drug Administration placed a clinical hold on its active investigational new drug applications. The biotechnology company said the FDA put a hold on its Ebvallo and ATA3219 programs due to compliance issues at a third-party manufacturing facility.

11hon MSN

FDA proposes mandatory front-of-package nutrition labels to combat spike in chronic diseases

The U.S. Food and Drug Administration (FDA) is demanding increased, in-your-face food transparency when it comes to nutrition ...

STAT18h

Three former FDA officials: Here’s what Trump and his nominees need to know

The FDA is the leading science-based consumer protection agency in the world. Three former senior officials write about what ...

13hon MSN

More than a dozen cats dead or sickened by bird flu in raw pet food, FDA says

More than a dozen cats have been killed or sickened by bird flu that is spreading in raw food products, the Food and Drug ...

13h

FDA makes key decision on Zyn nicotine pouches

In a statement, the FDA said it has authorized the marketing and sale of Philip Morris International’s Zyn nicotine pouches.

STAT13h

A next-generation form of chemotherapy wins FDA approval

Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

1don MSN

RFK Jr. wants to improve Americans’ health. Here’s some advice from the outgoing FDA chief

Robert F. Kennedy Jr. has big plans for the FDA if he's confirmed as Secretary of Health and Human Services. FDA Commissioner ...

Healio12h

FDA approves Datroway for advanced breast cancer

The FDA approved datopotamab deruxtecan-dlnk for treatment of certain patients with advanced breast cancer.The indication ...

20hon MSN

Milk Recall Update As FDA Sets Risk Class Over Spoilage Fears

19,688 cases of the milk overall were recalled, 8,654 of which had an expiry date of 3/3/2025, 7,385 with expiry date 3/4/2025, 1,781 with expiry date 3/6/2025, and 1,868 with expiry date 3/7/2025.

FiercePharma11h

Sanofi API plant hit with FDA warning letter detailing quality, consistency flubs

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

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FDA approves Johnson & Johnson’s nasal spray for depression

FDA, Atara Biotherapeutics

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